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Alcami Continues to Strengthen Senior Leadership Team with Appointment of Quality and Regulatory Leaders

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced further additions to strengthen its senior leadership team. Brian Dillion has been appointed to the role of Vice President of Regulatory Affairs and Quality Assurance and Jacquelyn Uribe has been appointed to the role of Vice President of Quality Operations. “Jacque and Brian bring broad compliance expertise with a track record of success upholding the rigorous standards required by both customers and regulators in high growth environments,” commented Chief Financial Officer Eric Evans.

Topics: News & Events

Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Ken Domagalski and Elliott Franco to their Senior Leadership Team. Ken Domagalski has been appointed to the role of Executive Vice President of Drug Product Operations and Elliott Franco has been appointed to the role of Vice President of Laboratory Operations.

Topics: News & Events

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

Topics: News & Events Editorials Parenteral Manufacturing

Alcami Announces Senior Leadership Appointments

WILMINGTON, NC – May 8, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Sally Langa and Kimberly McClintock to their Senior Leadership team. Sally Langa has been appointed to the role of Senior Vice President of Sales and Kimberly McClintock has been appointed to the role of Vice President of Marketing and Client Services.  

Topics: News & Events

Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Topics: Regulatory Compliance Drug Product Orphan Drugs Blogs

Alcami Supporting Potential COVID-19 Treatment

WOODCLIFF LAKE, N.J.—April 16, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New Jersey-based pharmaceutical company, today announced that its product RYANODEX® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (“CTAP”) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Topics: News & Events Parenteral Manufacturing

Editorial: Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Michael Reel, director of technical services at Alcami, and Quinn McGinnis, process engineer at Alcami, recently contributed to an article in Manufacturing Technology Insights titled Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas. In the article, Reel and McGinnis discuss solutions to pharmaceutical packaging challenges through straightforward case studies.

Topics: Editorials Packaging

Special Feature Editorial: Outsourcing Analytical Testing - Novel Services Elicit Consistent, Quantifiable, & Faster Results

Michael Freeman, associate director and business unit head for lab services at Alcami, recently contributed to an article in Drug Development & Delivery titled Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results. In the article, Freeman explains how Alcami's end-to-end analytical testing platform supports client programs through every stage of a product's lifecycle, from early phase development activities to commercial support for both small and large molecule products.

 

Topics: Editorials Analytical Testing Analytical Development

Editorial: High-Potency APIs -- Engineered for Safety

Mark Millar, director and business unit head for API at Alcami, recently participated in the high-potency APIs section of Speciality Chemicals Magazine. The write-up goes in-depth about investments being made in the high-potency API market and provides an overview into occupational health and safety challenges in manufacturing.

Topics: HPAPI Editorials

The Benefits of Establishing a Full-Time Equivalent (FTE) Program with Your Contract Service Provider

A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants pharmaceutical and biotech companies the flexibility, freedom, and consistent control of their outsourced laboratory programs. In this article, we will discuss the benefits of establishing a FTE program with an outsourcing partner and examine the customized solutions that are available for a broad spectrum of testing needs.

Alcami’s Extended Workbench offering is a FTE program tailored to your specific needs. An Extended Workbench program can vary in size, management approach, and scope, and is available across any pharmaceutical platform, from small molecule API to biologic drug product. 

Topics: Analytical Testing Blogs